Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K915895 |
Device Name |
STEALTH DILATION CATHETER SYSTEM (MODIFIED) |
Applicant |
TARGET THERAPEUTICS |
130 RIO ROBLES |
P.O. BOX 610458 |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
THERESA NAZAROFF |
Correspondent |
TARGET THERAPEUTICS |
130 RIO ROBLES |
P.O. BOX 610458 |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
THERESA NAZAROFF |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/17/1991 |
Decision Date | 06/04/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|